Study of Human Papillomavirus Related Genital Pathology Among HIV Positive Women

Summary

This study is a Multicentre cohort study with inclusion throughout the full duration of the study.

The primary objective is the study of human papillomavirus related genital pathology in HIV positive women.

The secondary objective are:

1. To study the characteristics of HPV infection and related disease in the context of long term HAART and HIV infection ;
2. To study the characteristics of atypical cells of uncertain significance detected in Pap smears, whose prevalence has dramatically increased in the last years;
3. To describe cervical cancers observed in the cohort
4. To study the evolution of recurrent high-grade lesions after surgery
5. To describe the evolution of vaginal lesions developed after hysterectomy for high-grade lesions ;
6. To describe the specific aspects of surgery for the treatment of cervical lesions according to the specific localization in the endocervix in HIV-positive women ;
7. To study the in situ T cell HPV specific response in cervical lesions and the relationship between virological and clinical parameters, host immune status and natural history of lesions ;
8. To initiate a prospective study on anal HPV infection and related disease among women infected with HIV.
9. To initiate a study on therapeutic and/or prophylactic HPV vaccines in the context of immunosuppression and a high rate of HPV infection ;

Conditions

• HIV Infections

Interventions

PROCEDURE

surgical management of high grade lesions

Clinical, pathological and biological, data at diagnosis and during follow-up will be collected. Surgical sample will be collected to study human papillomavirus related genital pathology.

Sponsors & Collaborators

• Virology study Heather A Cubie Catherine Moore Edinburg United Kingdom

  collaborator UNKNOWN

• Anatomopathology study Christine Bergeron Laboratoire Pasteur Cerba Cergy Pontoise France

  collaborator UNKNOWN

• Paris, Isabelle Cartier, M.D.

  collaborator INDIV

• Immunology study Guislaine Carcelain Groupe Hospitalier Pitié Salpétrière Paris

  collaborator UNKNOWN

• Surgery study Hervé Foulot Cochin Paris

  collaborator UNKNOWN

• French National Agency for Research on AIDS and Viral Hepatitis

  lead OTHER_GOV

Principal Investigators

• Isabelle Heard, MD · Unité biologie de la reproduction, GH Pitié Salpétrière

• Manuella Bonmarchand · Service Médecine Interne La Pitié Salpétrière

• Roland Tubiana · Service maladies infectieuses La Pitié Salpétrière

• Ana Canestri · Service maladies infectieuses La Pitié Salpétrière

• Catherine Creen Hebert · Service Gynécologie-obstétrique Louis Mourier

• Laurent Mandelbrot · Service Gynécologie Louis Mourier

• Francoise Meier · Service Gynécologie Louis Mourier

• Elisabeth Foucher · Service Gynécologie Louis Mourier

• Marie Jeanne Ducassou · Hopital de jour CISIH Marseille

• Isabelle Poizot Martin · Hôpital de jour CISIH Marseille

• Bénédicte Lefèvre · Service des maladies infectieuses St Antoine

• Bruno Carbonne · Service Gynécologie St Antoine

• Dahlia Torchin · Service Gynécologie St Antoine

• Anne Isabelle Richet · Service Gynécologie St Antoine

• Jean Paul Viard · centre de diagnostic et thérapeutique Hopital Hotel Dieu

• Christine Rousset Jablonski · Service Gynécologie Obstétrique Hopital Hotel Dieu

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2012-11-30

Completion

2012-12-31